510(k) · Cleared
ClearedMorcellex Sigma Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Sep 27, 2013 as substantially equivalent to K954648 (Gynecare Innovation Center, 1996) after a 113-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 27, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954648 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954648 Femrx Operastar SystemGynecare Innovation Center · 1996
- This deviceK131656 Morcellex Sigma GeneratorETHICON, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954648 | Femrx Operastar System | Gynecare Innovation Center | 1996 | — |
| 0 (this device) | K131656 | Morcellex Sigma Generator | ETHICON, Inc. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954648 | Femrx Operastar SystemSummary page 1…ry Class: 11 Product Codes: HET, Gynecologic laparoscope and accessories. Predicate Device: GYNECARE X-TRACT Motor Drive Unit (FEMRX OPERASTAR SYSTEM) - K954648 Device Description: The MORCELLEX SIGMA' m Generator provides mechanical power to the ETHICON laparoscop… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MORCELLEX SIGMA' m Generator is used with the following ETHICON Morceliation Devices: GYNECARE X-TRACT', GYNECARE MORCELLEX', and MORCELLEX SIGMA'. The MORCELLEX SIGMA Generator is used in conjunction with the ETH-ICON Morcellation Devices for gynecologic, urologic, and general surgical endloscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA TM Generator is used in conjunction with ETI-ICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131656: Morcellex Sigma Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131656
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026